Charities, Evidence and Vulnerable Minors

It’s about a year since Neon Roberts was famously spirited away by his mother to a holistic therapy refuge, in defiance of the courts, because she disagreed with the treatment options offered by his oncologist. As ever, it’s not a black and white case, and I have some sympathy with Mrs Roberts regarding one aspect at least. The story was told in a Channel 4 TV programme, which didn’t mention one important point. This was that Mrs Roberts wanted her son to be treated with proton beam therapy, among others.

Now this isn’t yet another bit of New Age pseudo-science, but a long established technique. For me, it challenges dearly held convictions about what evidence really is. The problem is that PBT hasn’t been tested in randomised controlled trials, and after some 40 years it’s too late to do them ethically. Follow the link for the explanation.

This difficult situation is recognized by the NHS, which funds some patients to travel to the USA for treatment, and government has agreed to fund the establishment of two PBT facilities in the UK. I am not of course in any position to know what Neon’s treatment should have been, but it does seem very slightly unfair that PBT didn’t get much attention in the media.

But let’s move on. Mrs Roberts’ safe house turned to be a charity operated by one Linda Scotson. Ms Scotson offers various therapies which she claims can improve neurological function in a range of conditions especially in children. Treatments appear to include hyperbaric oxygen, and respiratory exercises. Plausible as all this may sound, nowhere on Ms Scotson’s website is any actual evidence presented. There is a page which describes research carried out at Bradford University, but it emerges that the work was completed as a PhD project in 2005.

I have asked Ms Scotson where the research was published, and she replied that it is still being written up. I must say that she was most courteous on the phone and invited me to visit her centre. Interesting as that might be, it’s no substitute for proper evidence. Nine years is a very long time to write a PhD thesis. My last conversation with her was in April last year, and nothing seems to have been published since then. So I asked the Charity Commission to investigate. Here is my request:

The charity promotes treatments for certain medical conditions, in particular The Scotson Technique. No peer-reviewed evidence in support of the charity’s claims has been published. In April 2013 I asked the charity to provide such evidence, and was told that data were still being analysed, some 8 years after studies were claimed to have been completed. Now, 8 months later, the evidence has still not been published. Vulnerable people are misled by claims of benefit that cannot be substantiated. For example, in early 2013 the cancer patient Neon Roberts was the subject of a police search and court order, because his mother went on the run to avoid evidence-based treatment for her son. She found a `safe haven’ at this charity, where various unorthodox procedures were carried out. The child will have suffered harm from withdrawal of proper treatment, and this was a direct result of his mother being attracted by false claims of benefit by this charity.

I note that Ms Linda Scotson draws a full salary from the charity. I am not sure that making claims without adequate evidence, and thus encouraging donations, is proper conduct. Ms Scotson is not a trustee, but from the name of the charity it is obvious who is running it.

And here is their reply:

Thank you for your submission of 20 December.

The Charity Commission is the independent Regulator of charities in England and Wales. As such, our role is to ensure that trustees and others involved in the management and administration of charities comply with all aspects of charity law. We are not experts in the field of medicine or medical techniques and so the Commission is not the appropriate body to investigate the issues you have raised regarding the treatment offered by the charity. We would suggest that you raise your concerns with a body which is better placed to investigate those aspects of your complaint. I am not sure which organisation would be most appropriate but maybe the Care Quality Commission could assist or at least signpost you to the correct regulator.

I can confirm that the Commission is aware that Linda Scotson draws a salary from the charity. Her remuneration was authorised by way of an Order of the Commission dated 2 February 2001. The trustees are the persons responsible for the management and administration of the charity, Mrs Scotson, although the founder of the charity, is not on the trustee body and so has no role to play in its management although, if the trustees wished her to do so, she could act as an adviser to the trustees based on any specialist knowledge or skills she may have.

On the basis of the above, there is no regulatory action for the Charity Commission to take.

So I had another go:

Thanks for your reply, but I think you miss my point. Of course I realise that you are not experts in the field of medicine or medical techniques. But you are responsible for ensuring that charities comply with the law, which states that charities must operate for the public good. In my view the public is not served by claims that lack evidence and may well be misleading. The effect is that donations may be obtained on false premises, and vulnerable people may be distracted from obtaining effective treatment for serious diseases.

I do not expect the Charity Commission to decide what is a valid medical claim. I do expect you to seek qualified advice on such claims, and where they are found to be false to take appropriate regulatory action. In this case however, you do not even have to take such advice. Why not apply the standards which are successfully used by the Advertising Standards Authority? The ASA requires claims of health benefit to be backed up by peer-reviewed published randomised controlled trials. It is easy for anyone to search online to see whether such trials have been published. But even better, I have done the work for you. Not only have I searched and found no such published trials, but I have asked the charity making the claims and they admit that there are no such publications. You have nothing further to do but to ask the charity to back up their claims, and if they fail to do so to advise them that they are in breach of the law and to stop making the claims. Of course, if the charity’s raison d’être is based on false claims, then it begs the question as to whether the charity should continue. But I will leave that to you as regulator.

Your reply looks very much like a regulator trying to avoid doing their job. I hope I am wrong.

This time there was an unexpectedly positive response. Again, I was advised to seek guidance from the Care Quality Commission, which I have done. But at long last the Charity Commission agreed to ask Ms Scotson for confirmation that “the procedures and treatments on offer by the charity have been endorsed by the NHS or other appropriate professional medical bodies”. The Commission won’t undertake to advise me of the outcome, but at least we can look at the charity’s website to see if any action was taken. To my knowledge this is the first time that the Commission has taken any interest in health claims made by a charity, and sets a momentous precedent. There are of course countless other charities that will be affected, if this becomes a general rule.

The Care Quality Commission has so far (ie one week) not replied, but let’s give them more time.

Also featured on the Channel 4 programme was a certain Mark Givert who runs a company called Get FITT. Mrs Roberts bought lots of kit from him, for example a sort of flexible Faraday cage to shield her son from `electro-smog’. Using the excellent FishBarrel I submitted a complaint to the ASA. The problem with that was that there were too many false claims for the ASA online form – the whole site consists of false claims. I just had to submit a sample and say that these were representative of very many misleading claims.

The ASA eventually advised me that the case had been resolved informally, with the advertiser agreeing to remove the misleading claims. A couple of weeks after that I checked the Get FITT site again. Surprise surprise – it was now even worse, with new misleading claims and most of the old ones still there. In went another complaint, and this time the ASA said that the case will be referred for formal adjudication. Again, I had to submit a small sample of misleading claims and I hope the ASA will get the message and deal with the whole lot. They are normally very efficient and don’t miss a trick.

So here we have a story that hit the national headlines, where misleading claims of health benefit put a vulnerable child at risk. Don’t anyone tell me that quackery is harmless. And now you know that it just might be worth complaining to the Charity Commission. If you remember, I tried that before with The Maun Homeopathy Project, and got nowhere. Worth another go?

Update:

An interesting exchange with the Care Quality Commission ensued. I eventually got a reply, which to be brief just told me to look at their National Standards. These state that only health and care professionals fall within their remit, which seems to mean that anyone who doesn’t bother to get qualified won’t be regulated by the CQC. That’s not surprising, but this is – all alternative and complementary therapy is excluded. But they don’t define what that is. This of course was red rag to my bull, so I fired off this:

You will be aware that there is a range of schemes for regulating alternative and complementary therapy, but not a single one of these has the basic requirement of following evidence based practice. Any unqualified person can deliver what they claim to be health care, and because they are not from your perspective a health care professional, and they practise alternative and complementary therapy, they are unregulated and can do what they like. What is your view of that situation?

The reply was amusing:

I have liaised with our Regulatory Development Team who have advised that it would not be appropriate for CQC to provide a view on “whether any unqualified person can deliver what they claim to be health care, and because they are not from your perspective a health care professional, and they practise alternative and complementary therapy, they are unregulated and can do what they like.”

Obviously far too hot a potato for the CQC.

There have also been developments with Get FITT Ltd and the ASA. Initially, I was told that the ASA would escalate my complaint to a formal investigation, which would result in a published adjudication. But I have just been told that again the advertiser has agreed to remove a long list of misleading claims, so the case has been closed informally. Indeed he appears to have done so, but the site is still an alarming collection of gobbledegook about detoxification. But wait, at last I did find one reference to a published peer reviewed paper. But oh dear, it was authored by Dr Sarah Myhill, who enjoys an unenviable reputation after a succession of complaints about her to the GMC. In 2010 she was banned from prescribing drugs, and in 2012 was warned about the content of her website. Hardly a ringing endorsement for Get FITT Ltd.

Well, what option is there but to keep on sending in complaints to the ASA until the whole collection of garbage that is Get FITT disappears down the plug hole?

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5 Responses

  1. I have been trying to get the CQC to clarify whether some activities fall within their remit, but they seemed extremely unwilling to give a definitive answer, simply saying that a practitioner must decide for themselves whether or not the activities they carry out fall within the CQC’s remit or not. I cannot see that this is at all satisfactory.

    However, I have asked them specifically about Scotston and their hyperbaric chamber as it appears – at least on the face of it – to fall with in the CQC’s remit. I was told:

    Thank you for your enquiry about the hyperbaric treatment being offered by the Advance Centre for The Scotson Technique.

    Hyperbaric chambers would fall under our registration, subject to certain exemptions, if the care and treatment was being supervised by healthcare professionals. The regulated activity in this case would be the treatment of disease, disorder or injury. Most complementary therapy treatments however are exempt from registration.

    Having reviewed the Advance Centre web site it appears that the service is not being operated by healthcare professionals and the chamber is a type three, similar to that used by other complementary therapy organisations. These chambers were required to register under the Care Standards Act 2000 and this service was indeed registered by the Health Care Commission until that enactment was replaced by the Health and Social Care Act 2008. Under the current legislation this service falls out of the scope of registration and is no longer required to register.

    I have attached a link to the scope of registration that may help further.

    http://www.cqc.org.uk/sites/default/files/media/documents/20130717_100001_v5_0_scope_of_registration_guidance.pdf
    I hope that this answers your enquiry.

    Well, no it doesn’t really, but the startling point here is that if a procedure is supervised by a ‘healthcare professional’, then that activity must be registered with the CQC, but if it’s ‘supervised’ by a non-healthcare ‘professional’ it doesn’t need to be registered – treatments provided by quacks is exempt!

    Also, the chamber they use did once require to be registered but Lansley’s Health and Social Care Act removed that requirement.

    I find this astonishing.

    • The CQC’s policy mirrors that of the GMC, in that neither will regulate non-healthcare-professionals. One might naïvely assume that separate regulation of CAM might fill that gap, but of course evidence based practice is excluded from CAM regulation. So the quacks always get a free pass.

  2. Innocent until proven guilty is an important concept, but sometimes you wonder just how much evidence ( or lack thereof) is required to prompt various regulators to act.

    The systems seem fragmented, and no processes seems to be in place, nor any duty of care obvious, for one agency to be able to draw on the expertise of another to help informed decisions. It seems that each regulator often operates in isolation and as long they have completed their specific mandate requirements, then “there isn’t a problem”. Such loopholes are ripe for exploitation and the quacks appear to be adept at exploiting them.

    I wonder what the solution is? I am sure it would be pretty complicated but some inter agency cooperation not only appears sensible, but has the potential to prevent serious harm, or at the least stop some well intentioned people donating to charities because they accept claims uncritically. Many small charities are struggling in these tough economic times and, often hard-earned, donations wasted on nonsense have the knock on effect of preventing the good work of others.
    Thank you for this, it raises important issues, in a very well,reasoned way

  3. I just looked at the Care Quality Commission National Standards. Not only does the CQC exclude non-professionals from its remit, but also all alternative and complementary medicine. It’s the old old story, anyone seems to be able to do what they like if they make sure they don’t qualify for regulation. Or alternatively, be regulated by something like the CNHC which studiously avoids evidence based clinical practice.

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